AB1584 CONSENSUS RECOMMENDATIONS ON THE USE OF BIOSIMILARS IN THE TREATMENT OF INFLAMMATORY RHEUMATIC JOINT DISEASES
Authors: K. Alnaqbi, N. Al Adhoubi, S. Al Dallal, S. Al Emadi, A. Al-Herz, A. El Shamy, S. Hannawi, M. A. Omair, S. Saad, T. K. Kvien
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Biosimilars are highly similar to reference products and can help in reducing the financial burden and medication underutilization while still being comparable to reference products in treating rheumatic diseases<sup>[1]</sup>. <h3>Objectives</h3> The objective was to develop evidence-based consensus recommendations and overarching principles aimed at standardizing best practices for the use of biosimilars in treating patients with inflammatory rheumatic joint diseases in the Gulf region. <h3>Methods</h3> A taskforce comprising expert rheumatologists and healthcare economists formulated specific PICO questions on key topics concerning biosimilars: comparability of efficacy, safety and immunogenicity of biosimilars to reference products; extrapolation of indications for biosimilars; switching from reference products to biosimilars or between biosimilars; cost-savings; retention rates; nocebo effect among patients, and general awareness and perceptions of biosimilars in the Gulf region. A systematic literature review was conducted to identify, select, and critically appraise the quality of published evidence that demonstrated the value proposition of biosimilars in rheumatic diseases. Meta-analyses, clinical trials, and systematic reviews of adult patients treated with biosimilars for rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, and ankylosing spondylitis were included. As the data before 2017 has been previously reviewed in another publication,1 the current review focused on data published between January 2017 and August 2022 (PROSPERO ID CRD42022364002). Consensus on each statement required a level of agreement of 70% or greater. Another group of external stakeholders comprising rheumatologists, nurses, pharmacists, payers, regulators, and patients provided external validation of the statements. <h3>Results</h3> Consensus was reached for all the five overarching principles and eight recommendations by both the taskforce and the external stakeholders. The recommendations are largely congruent with previously published guidelines, with adaptation for regional clinical practice considering the nuances of the healthcare systems within the Gulf region. The overarching principles emphasize the importance of improving the awareness, understanding, and perceptions of biosimilars among rheumatologists, patients, and other stakeholders. They also highlight the need for collaborative efforts to gather regional real-world data and to make affordable biosimilars a viable treatment option for all patients. The consensus recommendations advocate the need for shared treatment decisions between rheumatologists and patients when considering a switch to, or between, approved biosimilars. They further recommend that confirmation of a biosimilar's efficacy and safety in a single indication is sufficient for extrapolation to other diseases for which the reference product has been approved. Finally, they highlight the need for regulated national and regional pharmacovigilance, post-marketing surveillance, and health policies governing the adoption and prescription of biosimilars in clinical practice across the Gulf region. <h3>Conclusion</h3> The outcomes of this initiative represent the second international and the first regional consensus recommendations for the Gulf region based on a systematic literature review, integrating clinical evidence with clinical expertise to optimize decision-making for the use of biosimilars in patients with rheumatic diseases. While the overarching principles and consensus recommendations were developed specifically for the Gulf region, they were formulated based on predominantly international data due to the lack of robust regional data. Therefore, we suggest that these statements can be generalized to serve as recommendations for healthcare providers also in other parts of the world. <h3>Reference</h3> [1] Kay J, Schoels MM, Dorner T, et al. Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis. 2018;77(2):165-74. <h3>Acknowledgements</h3> Medical writing support was provided by Connect Communications, Dubai, UAE. <h3>Disclosure of Interests</h3> Khalid Alnaqbi: None declared, Nasra Al Adhoubi: None declared, Sara Al Dallal: None declared, Samar Al Emadi Speakers bureau: Abbvie, Pfizer, and Johnson &amp; Johnson, Adeeba Al-Herz: None declared, Amin El Shamy Speakers bureau: Abbvie, AstraZeneca, Viatris, and Janssen, Grant/research support from: Abbvie, AstraZeneca, Viatris, and Janssen, Suad Hannawi: None declared, Mohammed A. Omair Speakers bureau: Abbvie, Pfizer, Amgen, Roche, Janssen, Hikma, Sandoz, Novartis, and BMS, Sahar Saad: None declared, Tore K. Kvien Speakers bureau: AbbVie, Amgen, Celltrion, Gilead, Grünenthal, Janssen, Novartis, Pfizer, Sandoz, and UCB, Grant/research support from: Research funding to Diakonhjemmet Hospital from AbbVie, Amgen, BMS, MSD, Novartis, Pfizer, and UCB.